Johnson & Johnson announced on Monday that it has filed an application with the U.S. Food and Drug Administration (FDA) to expand the use of its ketamine-based medication, Spravato, allowing it to be utilized as a standalone therapy for treatment-resistant depression.
The FDA initially approved Spravato in 2019, permitting its use in combination with an oral antidepressant for patients whose conditions did not improve after trying two or more other antidepressants.
According to Johnson & Johnson, nearly 30 percent of the 280 million individuals globally who suffer from major depressive disorder are affected by treatment-resistant depression.
“Many patients facing difficult-to-treat depression endure extended periods experimenting with multiple treatments that fail to alleviate their symptoms, which can impose a considerable functional and emotional toll on both patients and their families,” stated Bill Martin, head of neuroscience at Johnson & Johnson, in a press release.
The recent application is supported by data from a late-stage clinical trial indicating that Spravato, when used as a standalone treatment, began to alleviate patients’ symptoms as quickly as 24 hours post-treatment, with effects lasting for at least four weeks.
Spravato is administered as a nasal spray and must be taken under the supervision of a healthcare professional in a clinical setting. Unlike typical antidepressants that influence neurotransmitters like serotonin and dopamine, Spravato functions by increasing glutamate levels in the brain, which is the most prevalent neurotransmitter and facilitates neuronal communication.
Sales of Spravato surged by 60% to $271 million in the three months ending June 30, compared to the same period in 2023. The medication has been utilized by 100,000 people across 77 countries, according to Johnson & Johnson.